SARS-CoV-2 Process Control — Class II medical device recall Z-2486-2021
Terminated recall by Microbiologics Inc, reported 2021-09-29, distributed nationwide. The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV
| Recall number | Z-2486-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2021-08-20 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CO, DE, FR, GB, HK, IE, IN, IT, JP |
| Quantity | 218 |
| Lot numbers | HE0062-01-1, HE0062-01-2, HE0062-03-1, HE0062-04-1, HE0062-04-2, HE0062-05-1, HE0062-05-2, HE0062-06-1, HE0062-06-2 |
| Model numbers | HE0062S |
Product
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Reason for recall
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2486-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.